At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob Description:
目的と役割
Johnson & Johnson MedTechはOrthopaedics, Surgery, Electrophysiology, Neurovascularなど、複数の事業領域を展開しています。今回の募集では、Orthopaedics領域での薬事担当を想定したポジションです。該当するbusiness unitのRA managerにレポートします。
主な義務と責任
会社の事業戦略と整合させるように必要となる薬事のアクションを企画、準備し、実行することでビジネスの目標達成を支援する。
新製品導入等の担当プロジェクトに関する薬事戦略を構築し、海外製造元などの関係者に働きかけてサポートを得ながら、薬事申請を実行する。また、PMDAなどの審査機関や行政組織と交渉・連携し、迅速かつ確実に承認取得を達成する。
上市後の変更管理手続き等、製品を安定的に市場に供給し続けるため、あるいは、供給を終了するにあたり、関連法規制及び社内規定に従って関係者と連携し必要となる社内プロセス及び薬事に関する手続きを完遂する。
その他の義務と責任
社内規定に基づく広告審査業務及び海外製造元を含む社内関係者からの依頼や問い合わせへの対応
部門の優先課題など、組織的projectや活動への参加と貢献による価値創造
ビジネスの健全な成長と自社のreputationを維持、向上するために有効なコンプライアンス関連業務(主として薬機法)
必要な経験、スキル及びコンピテンシー
· 少なくとも5年以上の医療機器(クラスII以上)の薬事業務経験を有する。又はこれと同等と判断できるだけの経験を有する。
· 海外製造元の作成した設計開発文書(英語)を読解、理解することができ、また海外の社内関係者と口頭及び文章でコミュニケーションし、自らプロジェクトを推進することができる程度の英語力を有する。
あれば歓迎する経験、スキル及びコンピテンシー
· PMDA対面助言(医療機器開発前相談、非臨床試験の医療機器プロトコル相談・評価相談や医療機器臨床試験要否相談等)を担当としてリードしたことがある。
· 薬事業務全般について、自身で完遂できるだけでなく、他者やチームメンバーのサポート・支援経験。
· 修士以上の学位(工学、理学、農学、薬学、医学、歯学、生命科学・公衆衛生学等)
・If you are Japan employee, please read "Internal Application Guideline" in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan's employee, you are not able to apply for multiple positions at once.
・Once you move to 1st interview stage, please make sure to inform to your current manager.
・For Employee Referral Program (ERP), please read and understand the details of "Employee Referral Program" in Ask GS and make a compliant referral.
・応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。18か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。
・在籍期間に関わらず、書類選考を通して1次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。
・社内紹介を行う場合は、ASK GS上の"Employee Referral Program"の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。
-
Chiyoda myGwork - LGBTQ+ Business CommunityThis job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. · Johnson & Johnson believes health is everything and empowers us to build a world where complex diseases are prevented, treated, and ...
-
Chiyoda Johnson & Johnson MedTechJohnson & Johnson MedTech is expanding in multiple business areas, including Orthopaedics, Surgery, Electrophysiology, and Neurovascular. This position is for a Regulatory Affairs Manager in the Orthopaedics area, reporting to the relevant RA manager. · Plan, prepare, and execute ...
-
Chiyoda Johnson & Johnson Innovative Medicine Full timeJohnson & Johnson MedTech is expanding in multiple business areas, including Orthopaedics, Surgery, Electrophysiology, and Neurovascular. This position is for a Regulatory Affairs role in the Orthopaedics area, reporting to the RA manager of the relevant business unit. · Plan, pr ...
-
Chiyoda myGwork - LGBTQ+ Business Community ¥1,800,000 - ¥2,500,000 per year+This role involves maintaining regulatory approvals for general surgery products including sutures and tissue adhesives. · +Promptly managing regulatory compliance activities across various regions. · Establishing strong relationships with key stakeholders within local authoriti ...
-
Chiyoda Johnson & Johnson MedTech ¥4,000,000 - ¥6,000,000 per yearWe are seeking a RegulatoryAffairs Specialist to join our team at JohnsonandJohnson.The successful candidate will be responsible for maintainingand managing regulatory approvals for pharmaceutical products including surgical suturesand adhesives. · ...
-
Chiyoda Johnson & Johnson Innovative Medicine Full time¥4,000 - ¥10,500 per year+ · The company seeks an experienced professional for its regulatory affairs team responsible for maintaining management of Japan general surgery field products including sutures tissue adhesives etc. ...
-
Tokyo Takeda Full time¥4,000,000 - ¥8,000,000 per yearBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
-
Tokyo, Tokyo Takeda ¥2,500,000 - ¥5,000,000 per yearContribute to the appropriate use of self-medication and the improvement of drug therapy by providing, collecting, and transmitting information on the quality, efficacy, and safety of drugs to medical practitioners through face-to-face meetings or electronic tools. · Provide info ...
-
Tokyo Takeda PharmaceuticalJoin Takeda as a Medical Representative (MR) in the Japan Pharma Business Unit (JPBU) Second Business Unit, Sales Department, to contribute to the company's mission of improving people's health and well-being. As an MR, you will be responsible for providing medical information to ...
-
Tokyo, Tokyo Takeda ¥4,000,000 - ¥6,000,000 per yearAs a Sales Representative (MR) for Takeda's Japan Pharma Business Unit (JPBU) Second Business Unit, you will be responsible for providing medical information to healthcare professionals and promoting Takeda's pharmaceutical products. You will work closely with medical professiona ...
-
CMC-RA manager
3週間前
Tokyo Servier ¥120,000 - ¥180,000 per yearThe CMC RA Manager will lead and manage CMC regulatory activities, develop and implement CMC registration strategies, and support the development of the CMCRA team. The ideal candidate will have +10 years of practical experience with CMC-related roles, experience drafting and com ...
-
CMC-RA manager
3週間前
Tokyo SERVIER MONDE Full time¥900,000 - ¥1,200,000 per yearLead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...
-
Tokyo ICON plc ¥800,000 - ¥1,200,000 per yearSenior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mis ...
-
Tokyo Real ¥800,000 - ¥2,400,000 per yearWe are seeking a strategic business leader to drive growth for a leading healthcare solutions provider in Japan. This role offers the opportunity to shape the business unit strategy, lead cross-functional teams, and build strong partnerships with pharmaceutical clients and key st ...
-
PK specialist
5日前
Tokyo SERVIER MONDE Full time¥1,000,000 - ¥1,300,000 per yearLeveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value. · ...
-
Tokyo Thermo Fisher Scientific Full time¥4,000,000 - ¥12,000,000 per yearWe are looking for a Senior Financial Analyst to offer exceptional strategic and operational financial leadership at our Ibaraki, Japan site. This position presents an outstanding opportunity to engage with innovative individuals and generate a significant impact. · Deliver strat ...
-
Chiyoda Johnson & Johnson Full time¥4,000,000 - ¥12,000,000 per yearAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. · Provide ELD effectiven ...
-
PK specialist
5日前
Tokyo Servier ¥900,000 - ¥1,200,000 per yearLeveraging advanced kinetic analysis to drive efficient drug development · and maximize compound value. · ...
-
Project Leader
4週間前
Tokyo Parexel Full time¥5,000,000 - ¥10,000,000 per yearAt Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. · Contract content, pha ...
-
Director, Search
1ヶ月前
Tokyo パーソルキャリア株式会社 BRS ¥6,000,000 - ¥12,000,000 per yearDirector, Search & Evaluation, Business Development JAPAC · 日本から世界にイノベーションを届け、日本発の国際的なリーディングバイオ企業となることをビジョンとしています。 · Lead the end-to-end evaluation of potential assets—including scientific, commercial, and valuation model analysis—to inform CEO-level decisions. · Manage in-/out-l ...
-
Tokyo myGwork - LGBTQ+ Business Community ¥4,000,000 - ¥8,000,000 per yearAs an experienced Plant Finance Sr. Analyst, you will offer exceptional strategic and operational financial leadership at our Ibaraki, Japan site. This position presents an outstanding opportunity to engage with innovative individuals and generate a significant impact · Deliver s ...